Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Postoperative; Dysfunction Following Cardiac Surgery
- Sponsor
- University of Sao Paulo
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Composite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure)
- Last Updated
- 10 years ago
Overview
Brief Summary
The hypothesis of the study is to evaluate if the preoperative placement of IABP reduces clinical complications in high-risk patients undergoing cardiac surgery.
Detailed Description
High-risk patients undergoing cardiac surgery are at high risk for myocardial ischemia, arrhythmia, cardiogenic shock and other clinical complications. Different therapeutic options are available to support these patients in the perioperative period including inotropes, vasopressors, and vasodilators, and also assist devices such as intra-aortic balloon pump (IABP) and others. IABP increases myocardial oxygen supply by increasing diastolic coronary perfusion pressure and decreases myocardial oxygen demand by reducing left ventricular afterload. Additionally, IABP can also improve cardiac output and systemic perfusion. The hypothesis of this randomized and controlled trial is that the placement of IABP immediately before the cardiac surgery reduces clinical complications in high-risk patients.
Investigators
Ludhmila Abrahão Hajjar
Professor of Cardiology, University of Sao Paulo
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Age equal to or higher than 18 years old
- •EuroSCORE equal to or higher than 6 or ejection fraction equal to or lower than 40%
- •Written informed consent
Exclusion Criteria
- •Cardiogenic shock
- •Acute myocardial infarction (AMI) \< 48 hours
- •Mechanical complications of AMI
- •Peripheral vascular disease (aorta, iliac or femoral)
- •Severe aortic regurgitation
- •Pregnancy
- •Tachyarrhythmia
- •Procedures of the aorta
- •Coagulopathy
- •Thrombocytopenia
Outcomes
Primary Outcomes
Composite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure)
Time Frame: 30 days
Composite outcome of 30-day mortality or incidence of patients presenting a major complication according to modified Society of Thoracic Surgeons (STS): mechanical ventilation \> 24 hours, deep sternal wound infection/mediastinitis, surgical reexploration, stroke, cardiogenic shock and acute renal failure.
Secondary Outcomes
- Evaluation of hemodynamic data(48 hours)
- Delirium(30 days)
- Bleeding(24 hours)
- Duration of mechanical ventilation(30 days)
- IABP complications(30 days)
- Use of vasoactive agents(30 days)
- Levels of biomarkers(7 days)
- Echocardiographic parameters(7 days)
- Costs(30 days)
- 30-day mortality(30 days)
- 60-days mortality(60 days)
- 1-year mortality(1 year)
- Acute Kidney Injury(30 days)
- Cardiovascular complications(30 days)
- Infectious complications(30 days)